Comparison of Analgesic Efficacy of US Guided ESP Block With Port Site Infiltration Following Laparoscopic Cholecystectomy

NCT04167176 | Completed DMC

• 1 other identifier: ABC-3-DE
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the efficacy of ultrasonography (USG)-guided bilateral Erector spinae plane block (ESPB) with port-site infiltration using bupivacaine for post-operative analgesia after laparoscopic cholecystectomy with a hypothesis that both Erector spinae plane block and port-site infiltration are effective in providing post-operative analgesia.

Conditions

Postoperative Pain

Keywords

Cholecystectomy; ESP block; Port Site Infiltration

Outcome Measures

Primary Outcomes (1)

• Total postoperative opioid consumption.

  Nalbuphine consumption in mg.(equivalent to morphine dose)

  24 hours postoperatively

Secondary Outcomes (5)

• Pain scores;Numerical Rating Scale (NRS) at rest and when coughing

  at 1, 2,4 , 8, 16 and 24 hours postoperatively.

• •Cumulative postoperative analgesic consumption

  24 hours postoperatively

• •Heart Rate (HR)

  Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery

• •Mean Arterial Pressure (MAP)

  Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery

• Incidence and severity Postoperative nausea & vomiting (PONV).

  24 hours postoperatively

Study Arms (2)

Erector spinae plane block

ACTIVE COMPARATOR

ultrasound guided ESP Block after anaesthesia induction

Procedure: Erector spinae plane block; Device: Ultrasound machine (Mindray DP 9900 plus; Mindray Bio-Medical Electronics, Shenzhen, China); Drug: Bupivacaine 0.5%; Drug: Lidocaine 2%

Port site infiltration technique

ACTIVE COMPARATOR

After the induction of anaesthesia, pre-incisional port-site infiltration will be performed by the same surgeon every time with 20 ml of Local anesthetic (LA) mixture that will be divided equally between port sites

Procedure: Port site infiltration; Drug: Bupivacaine 0.5%; Drug: Lidocaine 2%

Interventions

Erector spinae plane block PROCEDURE

Patients will be placed on their right side. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. A 21G 10-cm needle will be inserted using an in-plane approach in a cranial to caudal direction. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. A volume of 20 mL of LA mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a mixture totaling 20 ml.) will be injected. The same procedure will be repeated for the opposite side.

Also known as: ESP block

Erector spinae plane block

Port site infiltration PROCEDURE

After the induction of anaesthesia, pre-incisional port-site infiltration will be performed by the same surgeon every time with 20 ml of the LA mixture. The volume will be divided equally between port sites. A total of four ports-supraumbilical, subxiphoid and two ports in the right subcostal area at mid-clavicular and anterior axillary line will be made.

Port site infiltration technique

Ultrasound machine (Mindray DP 9900 plus; Mindray Bio-Medical Electronics, Shenzhen, China) DEVICE

Ultrasound will be used to identify the erector spinae muscles and to guide the LA mixture injection.

Erector spinae plane block

Bupivacaine 0.5% DRUG

Bupivacaine 0.5% will be included in the injected LA mixture.

Erector spinae plane block; Port site infiltration technique

Lidocaine 2% DRUG

Lidocaine 2% will be included in the injected LA mixture.

Erector spinae plane block; Port site infiltration technique

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients with the American Society of Anesthesiologists (ASA) physical status I/II,
• Age between 18 and 60 years with a body mass index (BMI) of 18-35 kg/m2,
• Patients scheduled for elective laparoscopic cholecystectomy.

You may not qualify if:

• Allergy to local anaesthetics,
• Infection at the site of injection,
• , Coagulopathy,
• Chronic pain syndromes,
• Prolonged opioid medication,
• Patients who received any analgesic 24 h before surgery

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University hospital

Asyut, Asyut Governorate, 11111, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 18, 2019
• Study Start: September 15, 2020
• Primary Completion: September 17, 2022
• Study Completion: September 17, 2022
• Last Updated: December 20, 2022

Record last verified: 2022-12

Locations

EG (1)